Helio System (TF-FA), an investigational equipment developed for use with the Sapien XT Transcatheter Heart Valve, has been deployed successfully in four patients during a feasibility trial of its use in patients with high-risk aortic insufficiency.
Used as an anchor, the Helio dock system can help in stabilizing the Sapien XT valve for these patients.
New Zealand’s Waikato Hospital coronary and structural heart disease intervention specialist and the study’s lead author Sanjeevan Pasupati was quoted by healthcanal.com as saying this is an innovative and minimally invasive approach to treat pateints suffering with aortic insufficiency.
"What makes aortic insufficiency different from aortic stenosis – for which transcatheter aortic valve implantation (TAVI) is established – is the lack of calcium in the aortic leaflets and annulus, making it challenging to anchor the transcatheter heart valve. We need a system to anchor the valve in these patients," Pasupati added.
The four patients were kept under observation and were followed-up every 30 days, six months and 12 months. They will continue to be followed-up annually for another five years.
There were no in-hospital deaths even though one patient suffered with a stroke/TIA while another patient complained with minor vascular problems. A third patient who already had renal impairment suffered with an acute kidney injury.
According to the study, the primary endpoint of freedom from all-cause mortality at 30 days was 100%.
Bern University Hospital Switzerland Swiss Cardiovascular Center and Clinical Trials Unit Bern Cardiology professor and chief Stephan Windecker was quoted by Healthcanal.com as saying that the transcutaneous aortic valve implantation field is growing from its known established use in aortic stenosis to other aspects of aortic regurgitation.
"The larger annulus size in patients with aortic insufficiency without stenosis means we need facilitating techniques to use devices previously used in aortic stenosis. In this study it is encouraging to treat patients with aortic regurgitation for which we have not previously had suitable devices," Windecker added.